Workshop: Pharmacokinetic Drug-Drug interaction assessment
November 26 - November 28
€550.00 – €650.00
The GMP is proud to invite you to this new workshop entitled Pharmacokinetic Drug-Drug interaction assessment!
This 2-day workshop is co-organized by the directors of the Master 2 in PK (from universities of Lyon, Marseille, Paris and Toulouse), AFPT/Club Phase1 and the GMP.
For additionnal information, please contact contact@gmp.asso.fr or Olivier Nicolas (Olivier.nicolas@sanofi.com)
Workshop overview and objectives
This workshop is designed to provide to participants the necessary information needed to perform pharmacokinetic Drug-Drug interaction assessment. New Chemical and Biological Entities will be considered when applicable.
Registration fees (including lunch, coffee breaks and cocktail)
- Student rate: free registration (contact directly Olivier Nicolas (Olivier.nicolas@sanofi.com) via your Master II professor), 10 euros for membership (mandatory)
- Industrial/academic rate:
-
- Early bird (until October, 17th 2025) : 550€ + 50€ for non-members of GMP or AFPT.
- Standard fees: 650€ + 50€ for non-members of GMP or AFPT
- AFPT members need to contact Olivier Nicolas (Olivier.nicolas@sanofi.com) for manual registration
Agenda
| Time | Title | Speakers |
| Wednesday | ||
| 13:30 – 13:35 | Welcome | GMP/AFPT-CP1 |
| 13:35 – 15:05 | Review of ICH guidances/guidelines
· In vitro test · Strategy to assess in vitro DDI risk · DDI static prediction |
Priscilla Brun (Sanofi) |
| 15:05 – 15:30 | Coffee break | |
| 15:30 – 17:30 | Hands-on Drug-Drug Interaction on in vitro approaches
· DDI static predictions (including examples) |
Priscilla Brun/Olivier Nicolas (Sanofi) |
| Thursday | ||
| 9:00 – 10:30 | Mechanistic static approach
· Pharmapendium |
Olivier barberan (pharmapendium) |
| 10:30 – 11:00 | Coffee break | |
| 11:00 – 13:00 | Building a PBPK model to predict DDI
· Overview building and qualification PBPK model · Prediction for a drug as victim and as perpetrator
|
Mailys De Sousa Mendes (simcyp certara)
|
| 13:00 – 14:00 | Lunch |
| Time | Title | Facilitators |
| Thursday | ||
| 14:00 – 15:30* | Building a PBPK model to predict DDI
· Demo: prediction for a drug as victim and as perpetrator
|
Mailys De Sousa Mendes (simcyp certara)
|
| 15:30-16:00 | Coffee break | |
| 16:00-18::00 | Clinical DDI studies
· Study design : to which answers we want to reply · What other interactions than PK DDI · Examples- focus on strategy with : ->Cytochrome -> transporter
|
Henri Caplain/Yves Donazzolo (AFPT)/ Isabelle Deprez (GMP/Certara)
|
| 19:00 – 20:30 | Cocktail | |
| Friday | ||
| 9:00 – 11:00 | Regulatory HA
– Strategy – General approach for labelling recommendations – Examples |
Flora Musuemba (Federal Agency for Medicines and Health Products, Brussels, Belgium. University of Namur, Namur, Belgium)
|
| 11:00 – 11:30 | Coffee break | |
| 11:30 – 13:00 | Biologic DDI
– Review of guidelines – Case example |
Hélène Guillemin/ Florian Simon (sanofi) |
| * Including a coffee break | ||